Valsartil 80 Tab

What is Valsartil?

Valsartil is an angiotensin-II receptor blocker (ARB) containing the generic Valsartan, manufactured by Incepta Pharmaceuticals Ltd. It is used to lower high blood pressure and to improve outcomes in patients with congestive heart failure and after myocardial infarction.

Indications

Valsartil is indicated for hypertension, to reduce hospitalizations in patients with congestive heart failure, and to reduce death in patients who developed congestive heart failure after myocardial infarction.

Pharmacology

Valsartan is an oral, specific angiotensin II antagonist acting on the AT1 subtype. By blocking the action of angiotensin II, it dilates blood vessels and reduces blood pressure without affecting pulse rate. Valsartan has about 20,000-fold greater affinity for the AT1 receptor than the AT2 receptor and does not bind other hormone receptors or ion channels important in cardiovascular regulation.

Dosage & Administration

Hypertension: Usual dose is 80 to 160 mg once daily; maximum dose 320 mg daily. Maximum blood pressure reduction occurs within 4 weeks.
Heart failure: Usual dose is 40 mg twice daily, may be increased to 80-160 mg twice daily.
Post-Myocardial Infarction: Initial dose 20 mg twice daily, increased toward a target of 160 mg daily if tolerated.
Administration with food decreases absorption by about 40%, so it should be taken on an empty stomach. No initial dosage adjustment is required for elderly patients with mild to moderate renal and hepatic insufficiency.

Interaction

No drug interactions of clinical significance have been found. Studied compounds include Cimetidine, Warfarin, Furosemide, Digoxin, Atenolol, Indomethacin, Hydrochlorothiazide, Amlodipine and Glibenclamide. Concomitant use of potassium-sparing diuretics, potassium supplements, or potassium-containing salt substitutes may increase serum potassium.

Contraindications

Contraindicated in patients hypersensitive to any component of this product.

Side Effects

Generally well tolerated; side effects are rare. Common: headache, dizziness, fatigue, abdominal pain, cough, diarrhea, nausea. May also cause hyperkalemia, impotency, reduced renal function, allergic reactions, dyspnea, constipation, back pain, muscle cramps, rash, anxiety, insomnia and vertigo. Hypotension may occur with concurrent diuretic use.

Pregnancy & Lactation

Pregnancy Category D: Should not be used in pregnancy; can cause fetal injury or death in the 2nd and 3rd trimester. Discontinue as soon as pregnancy is detected.
Lactation: Not known whether excreted in human milk; weigh the importance of the drug to the mother against potential risk to the infant.

Precautions & Warnings

Use with care in hepatic impairment, including biliary obstructive disorders, as Valsartan is mainly eliminated via bile. Dosage reduction or discontinuation may be required in pre-existing renal impairment. Caution when initiating therapy in heart failure and post-myocardial infarction patients.

Overdose Effects

Limited human overdose data exist. Likely manifestations are hypotension and tachycardia; bradycardia may occur from vagal stimulation. If excessive hypotension occurs, place the patient supine and give IV normal saline if necessary.

Therapeutic Class

Angiotensin-II Receptor Blocker

Storage Conditions

Store between 15-30°C. Protect from moisture and heat.